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Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

This study has been terminated.
(The study was stopped due to difficulties in including patients)
Information provided by:
Ullevaal University Hospital Identifier:
First received: October 13, 2010
Last updated: November 1, 2010
Last verified: January 2003
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Condition Intervention
Heart Failure Cardiac Surgery Drug: levosimendan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Resource links provided by NLM:

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Need for inotropic agents or IABP (intra aortal balloon pump) [ Time Frame: jan 2003 - dec 2008 ]

Secondary Outcome Measures:
  • Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data. [ Time Frame: jan 2003-dec 2008 ]

Enrollment: 23
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1: Type of surgery
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
Drug: levosimendan
levosimendan 0.1 microgram/kg/min) for 24 hours
Other Name: Type of surgery

Detailed Description:
Single center, prospective, randomized parallel-group, double-blinded study

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • EF (ejection fraction)<40%

Exclusion Criteria:

  • renal failure, liver failure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01221116

Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Principal Investigator: Knut A Kirkebøen, MD, PhD Ullevaal University Hospital
  More Information

Responsible Party: Ullevaal University Hospital, Knut Arvid Kirkebøen Identifier: NCT01221116     History of Changes
Other Study ID Numbers: INSI-study
Study First Received: October 13, 2010
Last Updated: November 1, 2010

Keywords provided by Ullevaal University Hospital:
coronary artery disease,
aortic stenosis,
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs processed this record on August 21, 2017